Min-Gew Choi

Background: Hemogram is a novel biodegradable powdered hemostatic agent developed by binding calcium ions (Ca² ⁺ ) to carboxymethyl starch (CM-starch) and applying granulation technology to enhance blood absorption and hemostatic efficacy. This study aimed to evaluate the clinical efficacy and safety of Hemogram compared with the commercially available agent Arista™ AH in patients undergoing gastrectomy. Methods: This randomized controlled trial was conducted at Samsung Medical Center and included patients who experienced intraoperative oozing-type bleeding during gastrectomy. A total of 64 patients were enrolled and evenly randomized to receive either Hemogram (n = 32) or Arista™ AH (n = 32) for local hemostasis. The primary efficacy endpoint was the hemostatic success rate within 5 min. Secondary endpoints included hemostasis time, re-bleeding rate, number of hemostatic agent units used, transfusion volume, length of hospital stay, and incidence of adverse events. Results: Hemostatic success within 5 min was achieved in 100% (32/32) of the Hemogram group and 96.9% (31/32) of the Arista™ AH group, with no statistically significant difference between the two (P > 0.05). The mean time to hemostasis was 1.25 ± 0.80 min in the Hemogram group and 1.52 ± 0.85 min in the Arista™ AH group. No re-bleeding events were observed in the Hemogram group, while one case of re-bleeding (3.3%) was reported in the Arista™ AH group. There were no significant differences between groups in terms of transfusion volume, length of hospitalization, or adverse event rates. Conclusion: Hemogram demonstrated non-inferior hemostatic efficacy and safety compared to Arista™ AH in patients undergoing gastrectomy. These findings suggest that Hemogram is a promising and clinically applicable hemostatic agent for surgical use.

Evidence for the effectiveness of intensive nutritional counseling in reducing weight loss among patients who have undergone gastrectomy for gastric cancer is limited. We evaluated the effectiveness of intensive nutritional counseling in reducing weight loss after subtotal gastrectomy. We conducted a prospective, parallel-assigned, double-blind randomized clinical trial to assess the effectiveness of intensive counseling (IC) compared with simplified counseling (SC) in reducing weight loss among patients who underwent subtotal gastrectomy for early gastric cancer. Patients were randomly assigned to either the IC or SC group between March 2021 and February 2023, with a final follow-up in September 2024. Patients in the IC group participated in an IC program delivered by specialized clinical dietitians. Patients in the SC group received only standard counselling sessions before discharge. The primary outcome was the percentage change in body weight from baseline to 12 months after subtotal gastrectomy. A total of 258 patients were enrolled and randomized (122 in the IC group and 136 in the SC group), with 249 patients (96.5%) completing the 18-month follow-up period. At 12 months postgastrectomy, no statistically significant difference was observed in the percentage change in body weight between the 2 groups (0.09 percentage points; 95% confidence interval, -1.43 to 1.60). Other nutritional factors also showed no significant differences between the groups. Intensive nutritional counseling did not significantly reduce weight loss among gastric cancer patients after subtotal gastrectomy. Standard dietary counseling may be sufficient for dietary modification, although alternative approaches may be necessary. ClinicalTrials.gov Identifier: NCT04798820.

Background: Few studies have been conducted on the prevention of bile reflux in gastric cancer patients who have undergone gastrectomy. The aim of this study was to evaluate the efficacy and safety of ursodeoxycholic acid (UDCA) in preventing bile reflux after gastrectomy in patients with gastric cancer. Methods: This study was a secondary analysis of the PEGASUS-D trial, a randomized, double-blind, placebo-controlled clinical trial. Adults with a diagnosis of gastric cancer who underwent gastrectomy were enrolled. Eligible participants were randomly assigned to receive 300 mg of UDCA, 600 mg of UDCA, or placebo at a ratio of 1:1:1. UDCA and placebo were administered daily for 52 weeks. The primary outcomes included bile reflux symptoms at each time point, the percentage of participants with bile reflux, and the grade of gastritis. Results: Among 521 participants who underwent randomization, 151, 164, and 150 participants were analyzed from the 300 mg UDCA, 600 mg UDCA, and placebo groups, respectively. The difference in symptoms between the three groups was not significant. Bile reflux was less evident in the UDCA group than in the placebo group; however, this difference was significant only in the 300 mg group at 12 months postoperation (odds ratio, 0.44; P=0.0076). A significant reduction in gastritis was also observed in the 300 mg group at 12 months postoperation (odds ratio, 0.50; P=0.0368) compared to the placebo group. Conclusions: This study showed that UDCA administration significantly reduced bile reflux and gastritis by ~50% at the 12 months-postoperative follow-up in patients who underwent gastrectomy for gastric cancer.

Tae-Se Kim, Ji Yeong An, Min Gew Choi, Jun Ho Lee, Tae Sung Sohn, Jae Moon Bae, Yang Won Min, Hyuk Lee, Jun Haeng Lee, Poong-Lyul Rhee, Jae J. Kim, Kyoung-Mee Kim, Byung-Hoon Min. Gut and Liver 2024;18:807-13. https://doi.org/10.5009/gnl240006

Background and aims When treating undifferentiated-type early gastric cancer (UD-EGC) that is limited to the mucosa (clinically T1a), endoscopic submucosal dissection (ESD) can be considered if the tumor is 2 cm or less and is not ulcerated. However, there is insufficient evidence to determine the relationships between tumor size and oncological safety of ESD in UD-EGC. Methods The pathology reports of Korean patients who were diagnosed with UD-EGC (n = 5286) were retrospectively reviewed. The cumulative incidence of lymph node metastasis (LNM) according to tumor size was evaluated in subgroups. The tumor-size cut-off was identified as the upper limit of the 95% confidence interval (CI) of cumulative LNM incidence that did not exceed 1.0%. Results We identified 1516 patients with non-ulcerated T1a tumors ≤2 cm in size. Among patients without lymphatic invasion, 1.5% (95% CI 0.91–2.16%) had LNM. In patients with poorly differentiated tubular adenocarcinoma (PD), LNM increased from 0 to 0.74% based on a tumor size of 1.0 cm. Regardless of tumor size, smaller percentages of undifferentiated-type (UD) and poorly cohesive carcinoma (PCC) patients experienced LNM than did those with PD. In non-ulcerated mucosal cancer without lymphatic invasion and tumor size ≤0.9 cm, no LNM was observed in patients with UD (95% CI 0–0.53%), PCC (95% CI 0–0.59%), or PD (95% CI 0–0.86%) histologic type. Conclusion In patients diagnosed with non-ulcerated T1a UD-EGC, ESD can be performed if the tumor size is 0.9 cm or less, regardless of histologic type.

Dae Hoon Kim, Jeong-Meen Seo, Min-Gew Choi. Ann Clin Nutr Metab 2023;15:81-7. https://doi.org/10.15747/ACNM.2023.15.3.81

With the advances in chemotherapy and immunotherapy, a small subset of patients may be eligible for conversion surgery after achieving tumor regression with chemotherapy. This is a retrospective cohort study of 118 patients with stage IV gastric cancer who received palliative chemotherapy and conversion surgery with a negative resection margin at Samsung Medical Center. Baseline features included comorbidities, body mass index (BMI), carcinoembryonic antigen (CEA) level, primary tumor size, biopsy histology, distant metastatic sites, and molecular markers—HER2, MSI/MMR, PD-L1, and EBV. Post-chemotherapy features included BMI, CEA level, chemotherapy regimen, objective response to chemotherapy, and number of preoperative chemotherapy cycles. Post-operational features included tumor size, histologic differentiation and Lauren’s classification, pathologic tumor and nodal stages, invasion of lymphatics/vessels/nerves, peritoneal cytology, and the receipt of postoperative chemotherapy. Of 118 patients, 60 patients received total gastrectomy and 58 patients received subtotal gastrectomy. In all, 21 patients achieved a pathologic complete response, and 97 patients achieved downstaging to yp stage I, II, or III. Before conversion surgery, patients received first-line capecitabine/oxaliplatin (62%), HER2 inhibitors combined with chemotherapy (18%), immune checkpoint inhibitors (15%), and inhibitors of MET or VEGFR2 (5%). In the multivariable analysis, BMI at the time of diagnosis, either HER2 positive, high MSI, or deficient MMR, and the use of targeted agents were significant prognostic factors. Conversion surgery could be considered in patients with stage IV gastric cancer regardless of the initial disease burden. BMI and molecular markers are important prognostic factors that can be used to select candidates.

Supplementary Fig. 1: Mutation rate and ploidy for each individual patient's primary and metastatic sample (cohort 1);Supplementary Fig. 2: Validation of genomic heterogeneity within primary tumor and between primary tumor and lymph node (LN) metastases detected by next generation sequencing (NGS) with fluorescent in situ hybridization (FISH) and immunohistochemistry (IHC);Supplementary Fig. 3: PANGEA: Platform clinical trial of molecularly driven therapies in patients with previously untreated GEA;Supplementary Fig. 4: Biomarker profiling of PANGEA where the biomarker profiling of the metastatic tumor did not lead to treatment reassignment relative to treatments assigned based upon the primary tumor